醋氯芬酸英国药典2011

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1、Monographs:MedicinalandPharmaceuticalSubstancesAceclofenacGeneralNotices(Ph.Eur.monograph1281)C16H13CI2NO4354.289796・99・6ActionanduseCyclo-oxygenaseinhibitor;analgesic;anti-inflammatory.PhEurDEFINITION[[[2-[(2,6-Dichlorophenyl)amino]phenyl]acetyl]oxy]aceticacid・Content99.0percentto101.0percent(dri

2、edsubstanee).CHARACTERSAppearanceWhiteoralmostwhite,crystallinepowder.SolubilityPracticallyinsolubleinwater,freelysolubleinacetone,solubleinethanoI(96percent)・IDENTIFICATIONFirstidentificationB.SecondidentificationA,C・A.Dissolve50.0mginmethanolRanddiluteto100.0mlwiththesamesolvent.Dilute2.0mlofthe

3、solutionto50.0mlwithmethanolR.Examinedbetween220nmand370nm(2.2.25),thesolutionshowsanabsorptionmaximumat275nm.Thespecificabsorbanceattheabsorptionmaximumis320to350.B.Infraredabsorptionspectrophotometry(2.2.24).ComparisonPh.Eur.referencespectrumofaceclofenac・C・Dissolveabout10mgin10mlofethanol(96per

4、cent)R.To1mlofthesolution,add0.2mlofamixture,preparedimmediatelybeforeuse,ofequalvolumesofa6g/lsolutionofpotassiumferricyanideRanda9g/lsolutionofferricchlorideR.Allowtostandprotectedfromlightfor5min.Add3mlofa10.0g/lsolutionofhydrochloricacidR・Allowtostandprotectedfromlightfor15min.Abluecolourdevel

5、opsandaprecipitateisformed・TESTSRelatedsubstancesLiquidchromatography(2.2.29).Preparethesolutionsimmediatelybeforeuse.TestsolutionDissolve50.0mgofthesubstaneetobeexaminedinamixtureof30volumesofmobilephaseAand70volumesofmobilephaseBanddiluteto25.0mlwiththesamemixtureofsolvents・Referencesolution(a)D

6、issolve21.6mgofdiclofenacsodiumCRS(impurityA)inamixtureof30volumesofmobilephaseAand70volumesofmobilephaseBanddiluteto50.0mlwiththesamemixtureofsolvents.Referencesolution(b)Dilute2.0mlofthetestsolutionto10.0mlwithamixtureof30volumesofmobilephaseAand70volumesofmobilephaseB.Referencesolution(c)Mix1.0

7、mlofrefereneesolution(a)and1.0mlofrefereneesolution(b)anddiluteto100.0mlwithamixtureof30volumesofmobilephaseAand70volumesofmobilephaseB.Referencesolution(d)Dissolve4.0mgofaceclofenacimpurityFCRSand2.0mgofaceclofe